MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UN3 SCREWS, SELF-DRILLING, 1.5X4MM, 5/P; IMPLANT

Catalog Number	56-15904
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Distributor cannot return for evaluation.
Event or Problem Description
It was reported by the distributor that during the closure of the bone flap, the screw slipped several times before surgeon could completely drive in the screw in.There was no significant delay or patient harm reported.

• Brand Name: UN3 SCREWS, SELF-DRILLING, 1.5X4MM, 5/P
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8617851
• Report Number: 0008010177-2019-00018
• Device Sequence Number: 2130403
• Product Code: HBW
• UDI-Device Identifier: 34546540684920
• UDI-Public: 34546540684920
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K112557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 56-15904
• Device Lot Number: 1000297572
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1